Pancreas Adenocarcinomas Clinical Trial
Official title:
Prospective Evaluation of the Role of MRI in the Perioperative Management of Pancreas Adenocarcinomas
| NCT number | NCT03714542 |
| Other study ID # | 2016-00108 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | July 2016 |
| Est. completion date | June 2020 |
| Verified date | June 2020 |
| Source | University of Lausanne Hospitals |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The precision of MRI has improved over the past few years, in particular for the
hepatobiliary and pancreatic pathologies. The role of MRI in the management of operated
pancreas tumors remains nevertheless unclear and few studies have compared MRI to the actual
gold standard (CT). Compared to CT, MRI is not only a morphologic imaging technique but also
a functional imaging technique. MRI could therefore evaluate in a non-ionizing and dynamic
way several important pre- and postoperative aspects after pancreaticoduodenectomy (PD). This
study on the perioperative role of MRI includes 3 parts:
First, CT is known to minimize the real size of the pancreatic tumors and to underestimate
the vascular invasion correlated to resectability. The preoperative determination of the
resection surgical margins could be improved thanks to the high-contrast resolution of MRI.
Moreover, PD is a complex surgery encompassing a fragile anastomosis between the pancreatic
parenchyma and the digestive tract. The permeability of the pancreatic anastomosis after PD
remains presently unknown and has not been correlated to the clinical state of the patient.
MRI associated with secretin injection allows evaluating this permeability, which cannot be
done by CT due to the absence of functional evaluation.
Finally, present radiological follow-up after PD for tumors of the pancreatic head is
performed with CT. The MRI performance has not been demonstrated yet in the context of
follow-up. This imaging modality nevertheless offers unique specificities that are very
interesting and that could be helpful for the diagnosis of recurrence.
| Status | Completed |
| Enrollment | 50 |
| Est. completion date | June 2020 |
| Est. primary completion date | June 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - patients over 18 years old - indication for a PD for a resectable adenocarcinoma of the pancreatic head. Exclusion Criteria: - chronic pancreatitis - absence of discernment - patients not speaking French - preoperative radio/chemotherapy - patients with claustrophobia - patients with metallic implants. |
| Country | Name | City | State |
|---|---|---|---|
| Switzerland | University of Lausanne Hospital | Lausanne | Vaud |
| Lead Sponsor | Collaborator |
|---|---|
| University of Lausanne Hospitals |
Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Evaluation of the MRI precision in the delimitation of circumferential resection margins | The preoperative MRI results will be compared to the anatomopathological results. | Preoperative MRI performed up to one month before the operation date. | |
| Secondary | Evaluation of the potential correlation between the tumor size and the resection margins. | The preoperative MRI results will be compared to the anatomopathological results. Tumor size and resection margins will be measured in cm. | Preoperative MRI performed up to one month before the operation date. | |
| Secondary | Determination of the pancreatic anastomosis permeability | MRI with secretin injection | One year after the operation | |
| Secondary | Determination of the rate of exocrine insufficiency | Elastase test in the stool | One year after the operation | |
| Secondary | Correlation between anastomosis non-permeability and exocrine insufficiency. | Anastomosis non-permeability will be assessed with MRI with secretin one year after the operation. A score of permeability (number) will be appointed to determine permeability or not. Exocrine insufficiency will be defined by stool elastase measure <200 ug/g one year after the operation. | One year after the operation | |
| Secondary | Evaluation of a questionnaire for pancreas exocrine insufficiency | One year after the operation | ||
| Secondary | Evaluation of the MRI value to determine a recurrence in the follow-up of patients after PD | Comparison to the CT-scan | One year after the operation |